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Re: Generic vs Non Generic - Ed? SLS? Larry? » Maxime

Posted by Larry Hoover on June 7, 2005, at 18:05:49

In reply to Generic vs Non Generic - Ed? SLS? Larry?, posted by Maxime on June 7, 2005, at 14:21:47

> I think we have had this discussion before. About where generic versions of a med are as good as the brand.
>
> The only reason I am bringing it up again is because when I saw the psychopharmacologist he asked me whether I had taken generic Prozac or the brand version when it pooped out on me. I asked him if it made a difference and he said that if I had been taking the brand name and then switched to the generic form it could be one of the reasons it stopped working.
>
> Has anyone come across any articles about this? What are your thoughts?
>
> Cheers,
> Maxi

I can tell you that they are supposed to be "bioequivalent". They are supposed to deliver the same amount of active ingredient in the same amount of time.

Here is what the FDA has to say about generics:
http://www.fda.gov/cder/news/nightgenlett.htm
http://www.fda.gov/cder/about/whatwedo/testtube-17.pdf

However.....

How it is supposed to be, and how it really is....

How much faith do we put in studies of bioequivalency? I recall a fairly recent court case where a company that did these bioequivalency studies was accused of MAKING UP, TOTALLY FABRICATING potentially hundreds of studies upon which FDA rulings (or was it Health Canada rulings?) of bioequivlency were based.

The deal with proving bioequivalency is that the generic applicant doesn't have to prove that the drug works. The patented drug did that twenty years ago. The generic just has to show that in side by side comparison with the brand name drug, subjects had similar blood levels of active drug, lab samples had similar concentrations, blah blah. Well, apparently a private lab that did hundreds and hundreds of these studies just made up the numbers.

I know some doctors who have prescription pads that are pre-printed with the phrase "supply only as written" (or something like that) which means that a generic cannot be substituted for a brand name drug.

Caveat emptor. Buyer beware.

I am of the belief that my temazepam stopped working when the pharmacy switched generics from one supplier to another. Nothing I can do about that. Nor can I be sure that it really made a difference. The logical fallacy, "Post hoc ergo propter hoc; After this, therefore because of this" might apply. I.e. coincidence.

Lar

 

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poster:Larry Hoover thread:509126
URL: http://www.dr-bob.org/babble/20050606/msgs/509272.html